Ultrasound-Assisted Lumbar Puncture in Children

NCT ID: NCT03099642

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-10

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to determine if emergency physician performed ultrasound-assisted lumbar puncture improves first-time success rates in a pediatric population. This will be done by comparison with current landmark-based approach to the procedure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultrasound assisted lumbar puncture

The intervention of interest will be the ultrasound-assisted lumbar puncture (UALP). To do this, the treating physician will perform a bedside ultrasound of the spine to identify and mark the level of the conus medullaris and preferred puncture site prior to LP

Group Type EXPERIMENTAL

ultrasound-assisted lumbar puncture

Intervention Type RADIATION

The ultrasound probe type will be selected by the treating pediatric emergency physician who has been trained according to standards outlined below. They will first identify the conus medullaris and make a horizontal marking with a sterile pen on the patient's back. Using a transverse view, they will then identify the midline of the patient's spine (using adjacent spinous processes) and will make 2 vertical skin markings on either side of the probe. Next, they will orient the probe in a longitudinal view to identify the desired vertebral interspace and will make 2 horizontal skin markings on either side of the probe at this level. Finally the 4 lines will be joined together at an intersection point, which will be the predetermined site for puncture attempt.

Standard lumbar puncture

The control group will have a standard landmark-based lumbar puncture

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultrasound-assisted lumbar puncture

The ultrasound probe type will be selected by the treating pediatric emergency physician who has been trained according to standards outlined below. They will first identify the conus medullaris and make a horizontal marking with a sterile pen on the patient's back. Using a transverse view, they will then identify the midline of the patient's spine (using adjacent spinous processes) and will make 2 vertical skin markings on either side of the probe. Next, they will orient the probe in a longitudinal view to identify the desired vertebral interspace and will make 2 horizontal skin markings on either side of the probe at this level. Finally the 4 lines will be joined together at an intersection point, which will be the predetermined site for puncture attempt.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient less than 19 years of age
* Requiring a lumbar puncture as part of their work-up, as determined by the treating pediatric emergency physician.

Exclusion Criteria

* • Patients with known spine or spinal cord abnormalities

* Patients with ventricular shunts
* Patients deemed too unstable to have procedure performed
* Patients at risk for significant bleeding (coagulopathy, thrombocytopenia, etc)
* Parents unable to give consent or patients unable to assent for an acute reason
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jocelyn Gravel

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jocelyn Gravel, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Sainte-Justine Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sainte-Justine Hospital

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UALP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.